United States Prevention, Pesticides EPA712-C-96-343
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.4650
Aquatic Invertebrate
Range Testing, Tier
-------
INTRODUCTION
This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing of
pesticides and toxic substances, and the development of test data that must
be submitted to the Agency for review under Federal regulations.
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has developed this guideline through a process of harmonization that
blended the testing guidance and requirements that existed in the Office
of Pollution Prevention and Toxics (OPPT) and appeared in Title 40,
Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical Information Service (NTIS) and the guidelines pub-
lished by the Organization for Economic Cooperation and Development
(OECD).
The purpose of harmonizing these guidelines into a single set of
OPPTS guidelines is to minimize variations among the testing procedures
that must be performed to meet the data requirements of the U. S. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Final Guideline Release: This guideline is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
-------
OPPTS 885.4650 Aquatic invertebrate range testing, Tier III.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is OPP guideline 153A-27.
(b) Test standards. Data must be derived from tests that satisfy the
general test standards in OPPTS 885.0001 and OPPTS 885.5000 through
885.5400.
(1) Test organisms. Species most likely to be affected by the MPCA
should be used in this test. If a microorganism that is closely related (with-
in the same family) to the MPCA causes disease in a certain invertebrate
species, that species should be included in this test.
(2) Use pattern, (i) Microbial pest control agents that are expected
to enter freshwater ecosystems should be tested on freshwater aquatic in-
vertebrates. Likewise, if an estuary is likely to be impacted, marine inver-
tebrates should be included.
(ii) Testing should be performed on two members of the following
orders:
Freshwater—Cladocera, Copepoda, Ephemeroptera, Trichoptera.
Marine—Copepoda, Crustacea.
(3) Method of pesticide administration. The test substance shall be
administered either as a suspension in the test water (aqueous exposure)
and/or in the diet as determined from results of Tier I tests.
(4) Dose levels. The dose level shall be equal to that expected to
be found in the aquatic environment calculated from application rates with
appropriate adjustments to take into account the environmental survival
and multiplication characteristics of the MPCA being tested, as determined
by Tier II testing.
(5) Test duration. The test duration shall be the same as Tier I stud-
ies.
(c) Reporting and evaluation of data. The requirements in Tier I,
OPPTS 885.4050 and 885.4100, apply.
(d) Tier progression. (1) Further testing at Tier IV (OPPTS
885.4750) may be required if pathogenic effects are observed,
(2) Additional testing at higher tiers ordinarily is not required if path-
ogenic effects are not observed.
-------
(e) References. The following references should be consulted for ad-
ditional background material on this test guideline.
(1) American Public Health Association. Standard Methods for Exam-
ination of Water and Wastewater. 14th edition, Washington, DC (1975).
pp. 1193
(2) ASTM Standard E 729-80, Practice for Conducting Acute Tox-
icity Tests with Fishes, Macroinvertebrates, and Amphibians. American
Society for Testing and Materials, 1916 Race Street, Philadelphia, PA
19103.
(3) Bioassay Procedures for the Ocean Disposal Permit Program.
USEPA, Office of Research and Development. EPA-600/9-78-010;pp.
121 (1978).
(4) Banner, L.H. et al. A salt-water flow-through bioassay method
with controlled temperature and salinity, Progress in Fish-Culture 37:126-
129 (1975).
(5) Clark, J.R. and R.L. Clark, eds. Seawater systems for experimental
aquariums. US Interior Department, Fish and Wildlife Service, Bureau of
Sport. Fish. Wild. Research Report No. 63, 192 pp. (1964).
(6) Committee on Methods for Toxicity Tests with Aquatic Orga-
nisms. Methods for acute toxicity tests with fish, macroinvertebrates, and
amphibians. USEPA Ecological Research Series, EPA 660/3-75-009. 61
pp. (Marine and estuarine species listed in this publication are acceptable.)
(1975).
(7) Couch, J.A. et al. Environmental significance of baculovirus infec-
tions in estuarine and marine shrimp. Annals N.Y. Academy of Science
219:528-536 (1975).
(8) Couch, J.A. Design and Test of a Simple System for the Prelimi-
nary Evaluation of Infectivity and Pathogenesis of Insect Virus in a Non-
target Estuarine Shrimp. Journal of Invertebrate Pathology 43:351-357
(1984).
(9) DeBen, E.A. Design and construction of saltwater environment
simulator. Federal Water Quality Administration, Pacific N.W. Water Lab-
oratory, Working Paper 71:1-30 (1970).
(10) Hetrick, P.M. et al. Increased susceptibility of rainbow trout to
infectious hematopoetic necrosis virus after exposure to copper. Applied
Environmental Microbiology 37:198-201 (1979).
(11) Huang, E. and J.S. Pagano. Nucleic acid hybridization tech-
nology and detection of proviral genomes. Chapter 13 in The Atlas of In-
sect and Plant Viruses, K. Maramorosch, ed. Academic Press, NY(1977).
-------
(12) Ignoffo, C. M. et al. Susceptibility of aquatic vertebrates and
invertebrates to the infective stage of the mosquito nematode, Reesimermis
nielseni. Mosquito News 33:599-602 (1973).
(13) Lightner, D.V. et al. Testing Penaeid shrimp for susceptibility
to an insect Nuclear Polyhedrosis virus. Environmental Entomology 2:611-
613 (1973).
(14) Pagano, J.S. and E. Huang. The application of RNA-DNA
cytohybridization to viral diagnostics. In: Viral Immunodiagnosis. E.
Kurstak and R. Morisset, eds. Academic Press, NY (1974).
(15) Reynolds, G.J. Enzyme labelled antibody in histopathology.
Qualityline Winter 1978/1979:2-10 (1978).
(16) Shelbourne, HE. 1962. Experimental seawater systems for
rearing fish larvae. Pp.81-93 in Seawater Systems for Experimental
Aquariums. J.R. Clark and R.L. Clark, eds. U.S. Dept. Int., Fish. Wild.
Serv., Bur. Sport Fish. Wild. Res. Rep. No.63. 192 pp.
(17) Strickland, J.D.H., and T.R. Parsons. 1968. A practical handbook
of seawater analysis. Fish Res. Board Can. Bull. No. 167., 311 pp.
(18) Summers, M., R. Engler, L.A. Falcon, and P. Vail, eds.
Baculoviruses for Insect Pest Control: Safety Considerations. Selected pa-
pers from EPA-USDA Working Symposium, American Society for Micro-
biology, Washington, DC (1975).
(19) Tamer, M.F. et al. The tissue localization of Aeromonas
salmonicida in rainbow trout, Salmo gairdneri Richardson, following three
methods of administration. Journal of Fish Biology 25:95-108 (1984).
(20) Undeen A.H. and J.V. Maddox. The infection of nonmosquito
hosts by injection with spores of the microsporidan Nosema algerae. Jour-
nal of Invertebrate Pathology 22:258-265 (1973).
(21) Van Essen, F.W. and D.W. Anthony. Susceptibility of nontarget
organisms to Nosema Algerae (Microsporida: Nosematidae), a parasite of
mosquitoes. Journal Invertebrate Pathology 28:77-85 (1976).
(22) Weber, C.E. (ed.) Biological field laboratory methods for meas-
uring the quality of surface waters and effluents. USEPA Environmental
Monitoring Series, EPA-670/473-001 (1973).
------- |